PARIS--(BUSINESS WIRE)--May 18, 2011 - Final first-in man (FIM)
results from the BIOFLOW-I trial on the use of the Orsiro Hybrid
Drug-Eluting Stent (DES) were presented today in a late-breaking
clinical trials session at the EuroPCR congress in Paris by the
clinical coordinating investigator, Prof. Martial Hamon of
University Hospital of Caen, France.

BIOTRONIK's Hybrid Drug Eluting Stent (Photo: Business Wire)

The Orsiro Hybrid DES, which features the latest development in
BIOTRONIK stent technology, is a unique hybrid solution that
combines passive and active components. PROBIO®
passive coating encapsulates the stent and minimizes interaction
between the metal stent and the surrounding tissue.
BIOlute® active coating contains a highly
biocompatible polymer that delivers a limus drug via a
bioabsorbable matrix.

Orsiro is based on the leading PRO-Kinetic Energy bare metal
stent platform, renowned as the best performing because of its
advanced thin-strut stent design and outstanding
deliverability.

BIOFLOW-I was a prospective, multicenter, nonrandomized FIM
trial enrolling 30 patients. The objective of the study was to
assess the safety and clinical performance of the Orsiro Hybrid DES
as measured by freedom from major adverse cardiac events (MACE) and
in-stent late lumen loss at 9 months, evaluated by quantitative
coronary angiography (QCA). At 9 months, the results for the
primary endpoint in-stent late lumen loss were 0.05 ±0.22
mm. Two patients were symptomatic at 9 months, resulting in two
cases of clinically driven target vessel revascularization (TVR)
(6.7%). Clinical follow-up will continue annually out to at least 3
years.

Orsiro demonstrated sustained safety out to 9 months, as
indicated by absence of death, stent thrombosis and myocardial
infarction (MI).

“The results are especially encouraging considering the
challenging patient characteristics, atypical for a FIM
trial—a medical history including 73% previous MI and 23%
diabetic patients,” commented Prof. Hamon. “The
exceptional deliverability of Orsiro is a necessity with the degree
of complex stenting that is performed in current cath lab
practice.”

“We believe that the hybrid design of Orsiro will minimize
the potential for late adverse events due to its gently degrading
bioabsorbable polymer,” commented Alain Aimonetti, Vice
President of Sales and Marketing, BIOTRONIK Vascular Intervention.
“This bioabsorbable polymer leaves only a thin-strut stent,
optimally sealed from contact with tissue because of BIOTRONIK's
unique passive PROBIO coating.”

As a next step, BIOTRONIK is planning a comprehensive clinical
strategy to support the Orsiro Hybrid DES. BIOFLOW-II, a
pan-European, randomized, controlled trial with 440 patients
comparing Orsiro with Xience Prime™ DES, is currently being
initiated. Enrollment in BIOFLOW-III, a global, open-label registry
that will include 1000+ patients, will begin shortly.

“BIOTRONIK already offers a strong coronary and peripheral
passive device portfolio, and we will continue to introduce
innovative technologies such as last year's drug-eluting balloon
(DEB), Pantera Lux,” continued Aimonetti. “The exciting
addition of the Orsiro Hybrid DES allows us to offer the world's
most advanced product portfolio for vascular intervention and paves
the way for the drug-eluting absorbable scaffold we are
developing.”